BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES CLEARKONE HYBRID CONTACT LENS

    MDR report key: 3170019 · Received June 11, 2013

    Report

    Report Number
    3005087645-2013-00002
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K052675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL NUMBER: CK45M, ADDITIONAL LOT NUMBER: 047897, ADDITIONAL EXPIRATION DATE: 11/01/2017. NO REMEDIAL ACTION IS REQUIRED AS THE COMPLAINT COULD NOT BE CONFIRMED. VISUAL INSPECTIONS AND PARAMETER CHECKS (BASE CURVE AND POWER) FOUND THE LENSES TO BE WITHIN PARAMETER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PT HAS KERATOCONUS AND WAS UNABLE TO ADAPT TO SYNERGEYES CLEARKONE CONTACT LENSES ALTHOUGH SEVERAL ATTEMPTS AT REFITTING AND CHANGING THE PRESCRIPTION HAD BEEN MADE BY THE PHYSICIAN. ON THE LAST ATTEMPT OF FITTING, THE PHYSICIAN STATED THAT THE LENSES CAUSED SEVERE CORNEAL EDEMA/CORNEAL EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264828 SYNERGEYES CLEARKONE HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES, INC. CK50M-0700 047996

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention